42 CFR §405.205

1. (a)For any device that meets the requirements of the exception at § 411.15(o) of this chapter, the following procedures apply:
   1. (1)The FDA notifies CMS, when it notifies the sponsor, that the device is categorized by FDA as Category B (Nonexperimental/investigational).
   2. (2)CMS uses the categorization of the device as a factor in making Medicare coverage decisions.
2. (b)If the FDA becomes aware that a categorized device no longer meets the requirements of the exception at § 411.15(o) of this chapter, the FDA notifies the sponsor and CMS and the procedures described in paragraph (a)(2) of this section apply.